........... 6 3 Other Biographical Sketches (Not to exceed four pages for each - See instructions)) ........................ 7 2 Resources .................................................................................................................................................. 8 1 Enrollment Table ...................................................................................................................................... 9 1 Research Plan Page Numbe_ 1 Introduction to Revised Application (Not to exceed 3 pages) ......................................................................................................... Introduction to Supplemental Application (Not to exceed one page) .............................................................................................. 10 2 A. Specific Aims ......................................................................... _,_. .................................................................................... __. B. Background and Significance .................................................... | .................................................................................... I" 11 1 C. Preliminary Studies/Progress Report/ _ (Items A-D. not to exceed 25 pages*) .,_ 12 1 B Phase I Progress Report (SBIR/STTR Phase II ONLY) | * SBIR/STTR Phase h Items A-D limited to 15 pageB s. I D. Research Design and Methods .....................................................J.................................................................................. [unreadable] 13 5 E. Human Subjects ................................................................................................................................................................. 14 1 Protection of Human Subjects (Required if Item 4 on the Face Page is marked "Yes") 14 1 Inclusion of Women (Required if Item 4 on the Face Page is marked "Yes") ................................................................. 14 1 Inclusion of Minorities (Required if Item 4 on the Face Page is marked "Yes") ............................................................... 14 1 Inclusion of Children (Required if Item 4 on the Face Page is marked "Yes") ................................................................. 14 1 Data and Safety Monitoring Plan (Required if Item 4 on the Face Page is marked "Yes" and a Phase 1, II, or Ill clinical trial is proposed ...................................................................................................................................................... 14 1 F. Vertebrate Animals ............................................................................................................................................................. 15 1 G. Literature Cited ................................................................................................................................................................... 15 1 H. Consortium/Contractual Arrangements ............................................................................................................................... N/a I. Letters of Support (e.g., Consultants) ................................................................................................................................. N/a J. Product Development Plan (SBIR/S-I-FR Phase II and Fast-Track ONLY) .......................................................................... N/a Checklist .................................................................................................................................................... 16 1 Appendix (Five collated sets. No page numbering necessary for Appendix.) Check if Appendix is Included Appendices NOT PERMITTED for Phase I SBIR/STTR unless specifically solicited. Number of publications and manuscripts accepted for publication (not to exceed 10) Other items (list): PHS 398 (Rev. 05/01) Page 3 Form Page 3